Key Considerations for PCTs

What is a Pragmatic Clinical Trial

Section 5

Key Considerations for PCTs


Kevin Weinfurt, PhD


Contributing Editors

Karen Staman, MS

Jonathan McCall, MS

Liz Wing, MA

PCTs require different approaches to study design, start-up, conduct, oversight, review, and dissemination than traditional RCTs, although the current ethical, regulatory, and logistical systems were created with the more “traditional” RCT in mind (O’Rourke et al. 2015). To provide expertise to the NIH Collaboratory Demonstration Projects, several working groups, or Cores, were created to explore key elements of PCTs: electronic health records; phenotypes, data standards and data quality; patient-reported outcomes; health care systems interactions; ethics and regulatory; biostatistics and study design; and stakeholder engagement. In this textbook, we use information provided by the NIH Collaboratory Cores, Demonstration Projects, and the literature to explore these considerations for PCTs. We invite you to navigate through each section sequentially or by using the navigation menu to select a topic of interest.




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O’Rourke PP, Carrithers J, Patrick-Lake B, et al. 2015. Harmonization and streamlining of research oversight for pragmatic clinical trials. Clin Trials. 12:449–456. doi:10.1177/1740774515597685. PMID: 26374678.

Version History

Published August 25, 2017


Weinfurt K. What is a Pragmatic Clinical Trial: Key Considerations for PCTs. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated May 21, 2019. DOI: 10.28929/093.